MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT

Catalog Number ZVM08060

Device Problems Break (1069); Retraction Problem (1536); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.Information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide any further patient or procedural details to bard.Although this product is not sold in the u.S., this event is being reported under regulation 21cfr part 803 as it involves a similar device to a pma approved device sold in the u.S.Under # p080007.

Event Description

It was reported that during a stenting procedure for treatment of a stenosis in the common bile duct via transhepatic approach, resistance was met during advancement of the delivery system over a 0.035" guide wire to the target site.The stent could be deployed successfully.During removal of the delivery system, there was also high resistance and a part of the green inner catheter of the delivery system was found to be left on the guide wire.There was no reported patient injury.

Manufacturer Narrative

The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.There is no indication for a manufacturing-related failure.The evaluation of the returned device confirmed the successful deployment of the stent and that the 0.035" guide wire got stuck inside the guide wire lumen during the procedure.Compressive deformation of the inner and outer catheter indicated that a forceful attempt was made to retract the guide wire leading to the breakage of the inner catheter.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The reported event may be related to insufficient flushing of the delivery system prior to use or usage of inappropriately sized accessories.Increased release force leading to deformation and subsequent friction increase may be another contributing factor.The reported application represents an off-label use of the device which may be another contributing factor to the reported event.The fracture of the inner catheter is considered a consequence of the attempt to remove the guide wire from the system.On the basis of the information available and the evaluation of the returned device, a definite root cause for the reported event could not be determined.The ifu states that prior to inserting the delivery catheter over the guide wire, the system must be flushed with sterile saline at the two female luer ports until saline drips from the distal tip of the catheter.Also the ifu states that the e-luminexx vascular stent is only compatible with a 0.035" (0.89 mm) guide wire.Furthermore, the ifu indicates: "should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit." and "visually inspect the e-luminexx vascular stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment." and "after removing the delivery system, visually confirm that the entire stent delivery system has been removed." in addition, the ifu indicates that the e-luminexx vascular stent intended for use in the iliac and femoral arteries.(b)(4).

Event Description

It was reported that during a stenting procedure for treatment of a stenosis in the common bile duct via transhepatic approach, resistance was met during advancement of the delivery system over a 0.035" guide wire to the target site.The stent could be deployed successfully.During removal of the delivery system, there was also high resistance and a part of the green inner catheter of the delivery system was found to be left on the guide wire.There was no reported patient injury.

• Brand Name: E-LUMINEXX VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 6657174
• MDR Text Key: 78094061
• Report Number: 9681442-2017-00204
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: ZVM08060
• Device Lot Number: ANBQ2655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR